Phase IIB Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Total Toxicity Burden (TTB)
研究概览
简要总结
The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer.
PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue. However, this is still being studied.
详细描述
Study Treatment:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:
- If you are in Group 1, you will receive IMRT.
- If you are in Group 2, you will receive PBT.
You will receive radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.
Your doctor may think it is in your best interest to also receive chemotherapy while you are receiving radiation therapy. If this occurs, you will sign a separate consent form for these drugs with a full description of how they are given and the risks they may cause.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18
- •Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
- •Potentially resectable or unresectable esophageal cancer patients
- •Induction chemotherapy prior to concurrent chemoradiation allowed
- •Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible
- •Performance status of Karnofsky Performance Scale (KPS) >/= 60 or Eastern Cooperative Oncology Group (ECOG) = 0, 1, or
- •Prior thoracic radiation allowable only if there is minimal to no overlap with the treatment area estimated at the time of consultation.
- •Negative pregnancy test (serum or urine) for women of child bearing potential. All protocol participants must agree to adequate contraception.
- •Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, Carbon Dioxide (CO2), Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, Alanine Aminotransferase (ALT) Serum Glutamic Pyruvic Transaminase (SGPT), Aspartate Aminotransferase (AST) Serum Glutamic-oxaloacetic Transaminase (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) >2,500/uL, platelets > 75,000/uL), renal (Serum creatinine </= 1.5X Upper Limit of Normal (ULN) or creatinine clearance > 50 mL/min), and liver function (bilirubin </=1.5 fold the upper limit of normal and liver enzymes < 3 fold the upper limit of normal)
- •Able to communicate in the English language.
- •Any patient deemed eligible for chemoradiation for esophageal cancer treatment.
排除标准
- •Patients with active second malignancy are allowed as long as it is determined by the treating physician that the treatment of esophageal cancer is of higher priority through proper evaluation. However patients with active stage 4, metastatic cancers, receiving other systemic therapies at the time of the esophageal cancer diagnosis, will not be eligible.
- •Pregnant or breast-feeding females
- •Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection; b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device; c) no myocardial infarction within 3 months of registration
- •Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone.
研究组 & 干预措施
Proton Beam Therapy (PBT)
Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy (or at RBE ("Relative Biologic Equivalence" for PBT)) to be delivered to the periphery of the planning target volume (PTV).
干预措施: Proton Beam Therapy (PBT) (Radiation)
Proton Beam Therapy (PBT)
Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy (or at RBE ("Relative Biologic Equivalence" for PBT)) to be delivered to the periphery of the planning target volume (PTV).
干预措施: Questionnaires (Behavioral)
Intensity Modulated Radiation Therapy (IMRT)
Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy to be delivered to the periphery of the planning target volume (PTV).
干预措施: Intensity Modulated Radiation Therapy (IMRT) (Radiation)
Intensity Modulated Radiation Therapy (IMRT)
Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy to be delivered to the periphery of the planning target volume (PTV).
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Total Toxicity Burden (TTB)
时间窗: 12 months
TTB defined from the time of randomization to 12 months after randomization. Total toxicity burden (TTB) is computed as a composite score from serious adverse events (SAEs) and, among patients who undergo surgery, postoperative complications (POCs).
Progression-Free Survival (PFS)
时间窗: 6 weeks after radiation therapy
Defined from the time of enrollment to the date of death or any recurrence. The progression-free survival (PFS) time distribution will be estimated in each treatment arm using the Kaplan-Meier method.
次要结局
未报告次要终点